Prodimed recalls pediatric catheters for blind bronchial sampling due to potential lack of sterility. Affected units include Combicath 35cm x 1.9mm with product code 58 223 19US and all lots within expiry.
Lack of assurance of sterility
Prodimed is recalling pediatric catheters used for blind bronchial sampling because they may not be sterile. This could lead to infections or other health risks if used improperly.
The catheters may not be sterile, which could cause infections in patients during medical procedures. This is a risk when used for invasive procedures without proper sterilization.
Pediatric patients requiring blind protected distal bronchial sampling. Healthcare providers using these catheters are most at risk of infection.
Check for the product code 58 223 19US on the Combicath 35 cm x 1.9 mm catheters. All lots within expiry date are affected.
Look for product code 58 223 19US on the catheter packaging or label.
The recall is due to a lack of assurance of sterility, which could lead to infections during medical procedures.
Check the product code 58 223 19US on the catheter. If it matches, contact Prodimed for further instructions.
Yes, all lots within expiry date are affected by this recall.
We’ve drafted a message you can send Prodimed to request your refund or repair — edit it as you like.
Subject: Recall Z-2491-2020 — Prodimed Prodimed Hello, I own a Prodimed that is covered by recall Z-2491-2020 from Prodimed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
